New Treatment Modalities for Localized Prostate Cancer

Summary

The purpose of this study is to evaluate the effectiveness of four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and long-term follow-up. The primary aim is assessing the impact of treatments' side effects on patient's quality of life. As secondary objectives, biochemical disease-free survival, overall survival, and prostate cancer-specific survival will also be assessed.

Conditions

• Prostate Cancer

Interventions

PROCEDURE

Active Surveillance

It consists on monitoring the cancer with regular tests including PSA, blood test and digital rectal examination every 6 months, a magnetic resonance imaging and prostate biopsy at the first year, and based on clinical decision thereafter. If there was a change on the results, the patient is considered for treatment.

PROCEDURE

Robot-Assisted Radical Prostatectomy

It consists on the removal of the prostate gland and seminal vesicles with neurovascular preservation whenever anatomically and oncologically possible, with the Da Vinci procedure. Access is made through 5 or 6 small incisions, less than 1 cm. An extended pelvic lymph node dissection is performed when the risk estimation of node involvement is above the 5%. After surgery, the patient will be hospitalized for about 3 days and will probably resume his work activity between 3 and 5 weeks.

RADIATION

Intensity-Modulated Radiotherapy

Patients in this group undergo volumetric modulated arc therapy under daily image-guided radiation therapy in the supine position. Radiation is delivered in 2-3 Gy daily fractions, 5 days per week, with a prescription dose of 60-70 Gy to the prostate.

RADIATION

Real-time brachytherapy

Patients in this group receive I125 permanent seeds (low dose rate). The images are obtained with a transrectal ultrasound probe and are transferred to a planning system for calculating the number and position of the seeds. The prescrption dose is 145 Gy to the reference isodose (100%).

Sponsors & Collaborators

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Institut d'Investigació Biomèdica de Bellvitge

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• Hospital Regional Universitario Carlos Haya

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Hospital Universitario Rey Juan Carlos

  collaborator OTHER

• Hospital Provincial de Castellon

  collaborator OTHER

• Hospital Arnau de Vilanova

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital de Meixoeiro

  collaborator OTHER_GOV

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Hospital General Universitario de Valencia

  collaborator OTHER

• Fundacion IMIM

  lead OTHER

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2014-04-30

Completion

2027-12-31